FDA.reportPublic FDA data

Surgical irrigator

Primary DI
10803622104067
Brand
Surgical irrigator
Company
LIVANOVA USA, INC.
Model
MT-xxxxx
Published
2015-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FQHLAVAGE, JET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622104067PackageGS15In Commercial Distribution
00803622104060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362210406710803622104067
00803622104060008036221040608036221040600803622104060

GMDN Terms#

Term, Definition table
TermDefinition
Surgical fluid/gas irrigatorA sterile, hand-operated surgical device intended for the controlled delivery of medical gas and fluid (e.g., saline solution) to an open surgical site to improve visibility, by clearing bloody fluids/debris, and to prevent tissue desiccation. It is typically made of plastic materials [e.g., polypropylene, polyvinyl chloride (PVC)] and may be double-lumen for nebulization of fluid/gas, or dual-line for separate fluid and gas administration and include an antibacterial filter. It typically includes a nozzle at the distal end and connector(s) [e.g., Luer] at the proximal end for connection to the fluid/gas sources; a manual tubing clamp may also be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080914995
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622164736Perfusion PackPerfusion Pack2026-09-29
00803622164743Perfusion PackPerfusion Pack2026-09-29
00803622164859Perfusion PackPerfusion Pack2026-09-29
00803622164651Perfusion PackPerfusion Pack2026-09-28
00803622164675Perfusion PackPerfusion Pack2026-09-28
00803622164682Perfusion PackPerfusion Pack2026-09-28
00803622164705Perfusion PackPerfusion Pack2026-09-28
00803622164712Perfusion PackPerfusion Pack2026-09-28
00803622164729Perfusion PackPerfusion Pack2026-09-28
00803622164767Perfusion PackPerfusion Pack2026-09-28
00803622164378Perfusion PackPerfusion Pack2026-09-22
00803622164477Perfusion PackPerfusion Pack2026-09-22
00803622164514Perfusion PackPerfusion Pack2026-09-22
00803622164569Perfusion PackPerfusion Pack2026-09-22
00803622164576Perfusion PackPerfusion Pack2026-09-22
00803622164583Perfusion PackPerfusion Pack2026-09-22
00803622164590Perfusion PackPerfusion Pack2026-09-22
00803622164606Perfusion PackPerfusion Pack2026-09-22
00803622164613Perfusion PackPerfusion Pack2026-09-22
00803622164668Perfusion PackPerfusion Pack2026-09-22

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Primary DI, Brand, Company table
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00850022135347VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
05051471221512De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2026-05-27
B674PL30010PerilavStiehl Tech, LLCFQH2026-05-13
B674T93LF10PerilavStiehl Tech, LLCFQH2026-05-13
07640407460811debritom+Medaxis AGFQH2026-04-17
07649996166302debritom+Medaxis AGFQH2026-04-17
07649996166043debritom+Medaxis AGFQH2026-04-08
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00850073677032Shur-ClensAsept Pak, Inc.FQH2026-02-17
00850073677056Skin-ClensAsept Pak, Inc.FQH2026-02-17
10850073677008Shur-ClensAsept Pak, Inc.FQH2025-04-30
10860006476035Shur-ClensAsept Pak, Inc.FQH2025-04-23
10850073677015Shur-ClensAsept Pak, Inc.FQH2025-04-16
10860006476028Shur-ClensAsept Pak, Inc.FQH2025-04-16
10842351180027Irrisept Accessory KitIRRIMAX CORPORATIONFQH2024-07-22
10842351120047Irrisept Antimicrobial Wound LavageIRRIMAX CORPORATIONFQH2024-07-16
10842351180010Irrisept Wound Solution KitIRRIMAX CORPORATIONFQH2024-07-01
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06951233720361CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720378palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720507palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720545CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720569PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11